510(k) Report

510(k) · Cleared

Cleared

Pulse*Spray Infusion System

K950907510(k) TraditionalCleared May 17, 199593-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Angiodynamics, Div. E-Z-Em, Inc. · QEY Mechanical Thrombolysis Catheter

Cleared on May 17, 1995 after a 93-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 77 devices in its family, counting itself, have a Class I recall. 76 later devices descend from it.

Decided
May 17, 1995
Review
93 days
Class
Class II
Product code
QEY
Recalls
None
Predicates
0

76 later devices descend from it, 3 citing it directly. 2 of the 77 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2014: 1 descendant cleared2003: 3 descendants cleared2002: 3 descendants cleared2008: 7 descendants cleared2004: 5 descendants cleared2005: 9 descendants cleared2020: 4 descendants cleared2022: 3 descendants cleared2006: 6 descendants cleared2007: 6 descendants cleared, 1 with a Class I recall12016: 3 descendants cleared2023: 3 descendants cleared2024: 5 descendants cleared2025: 2 descendants cleared2013: 1 descendant cleared, 1 with a Class I recall12026: 6 descendants cleared2011: 1 descendant cleared2019: 4 descendants cleared2018: 2 descendants cleared2021: 2 descendants cleared1995200020052010201520202025
  1. This deviceK950907 Pulse*Spray Infusion SystemAngiodynamics, Div. E-Z-Em, Inc. · 1995
  2. Descendant · cites it directly · 75 of its ownK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
  3. Descendant · 2 generations on · 57 of its ownK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
  5. Descendant · cites it directly · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  6. Descendant · 2 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2002: 32003: 32004: 52005: 92006: 62007: 62008: 72011: 12013: 12014: 12016: 32018: 22019: 42020: 42021: 22022: 32023: 32024: 52025: 22026: 6
2002high 9 (2005) · low 0 (2009)2026

Class I recalls in this family

  • K071664 Trellis-6 Peripheral Infusion System5 generations on · 2007
  • K130904 Trellis-8 Peripheral Infusion System5 generations on · 2013

Most influential descendants

Showing 5 of 76 · See all
  • K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc. · 2002 · cites it directly75descendants
  • K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc. · 2002 · 2 generations on57descendants
  • K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · 2 generations on56descendants
  • K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · cites it directly50descendants
  • K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 2 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950907Pulse*Spray Infusion SystemAngiodynamics, Div. E-Z-Em, Inc.1995—
+1K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…Bacchus Vascular, Inc.2002—
+2K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…Bacchus Vascular, Inc.20021
+2K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc.20021
+1K030637Ekos Peripheral Infusion SystemEkos Corp.2003—
+2K033214Ekos Peripheral Infusion SystemEkos Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200330
200450
200590
200660
200761
200870
201110
201311
201410
201630
201820
201940
202040
202120
202230
202330
202450
202520
202660
FIG. 1 — Lineage of K950907, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QEY device

  1. #1 K241851 Versus™ Catheter (VS110-8B)score 16.8 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (76)

See all 76

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc.200275
K030637Ekos Peripheral Infusion SystemEkos Corp.200350
K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
  • K130904Trellis-8 Peripheral Infusion SystemCovidien · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K013635 (Bacchus Vascular, Inc., 2002) has gone furthest, with 75 descendants of its own.

How does its category compare?

All QEY devices

QEY Mechanical Thrombolysis Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QEY

1in 2024

2007: 52008: 42011: 12013: 12014: 12015: 12016: 22017: 32018: 12019: 52020: 32021: 32022: 12023: 22024: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEY

62in 2021

2007: 28 days median2008: 54 days median2017: 144 days median2019: 91 days median2020: 158 days median2021: 62 days median
2007high 158 (2020) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QEY

1in 2023

2022: 12023: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QEY

5in 2025

2023: 12024: 12025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code QEY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200752800
200845400
20090—00
20100—00
20111—00
20120—00
20131—00
20141—00
20151—00
20162—00
2017314400
20181—00
201959100
2020315800
202136200
20221—10
20232—11
20241—01
20250—05
20262—0—

More from Angiodynamics, Div. E-Z-Em, Inc.

6 FDA decisions under this applicant name. See the company

  • K961763Pulse*Spray Infusion SystemAngiodynamics, Div. E-Z-Em, Inc. · 19963 recalls
  • K951509Pulse*Spray Infusion SystemAngiodynamics, Div. E-Z-Em, Inc. · 19952 recalls
  • K951602Pulse*Spray Infusion SystemAngiodynamics, Div. E-Z-Em, Inc. · 19953 recalls
  • K933846Angiography Syringe KitsAngiodynamics, Div. E-Z-Em, Inc. · 19941 recall
  • K923120Microguide Lesion Marking SystemAngiodynamics, Div. E-Z-Em, Inc. · 1992

Recent decisions in QEY

The QEY category page

  • K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc. · 2026
  • K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc. · 2026
  • K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
  • K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc. · 2023
  • K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc. · 2023

https://510kreport.com/device/K950907 · printed Nov 5, 2026

Cite this page

510(k) Report. “K950907: Pulse*Spray Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950907

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026